Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204087
Company: ENCUBE
Company: ENCUBE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/27/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |